This invention relates to human infertility, in particular the apparent inability of certain women to conceive. There are many currently known causes of infertility, including: abnormality in the male partner, ovulatory disorder, abnormal sperm-cervical mucus interaction, tubal obstructive disease and/or endometriosis, luteal phase defect, and a variety of peritoneal, ovarian and immunologic factors. Many women, however, fail to conceive despite all current diagnostic studies for infertility being normal.
One approach to treatment involves an effort to understand and remedy an infertile woman's own ability to conceive. There have been theories advanced in the art to identify the causes of infertility which cannot be explained by the causes set forth above, and a wide variety of etiologic factors are being currently investigated. Current theories include luteinized unruptured follicle syndrome, autoantibodies against the zona pellucida, or failure of implantation of the conceptus. However, none of these theories currently aid the clinician in directing treatment for unexplained infertility, and past therapies have been largely empiric in nature.
Alternative approaches to treatment involve compensating for a women's inability to conceive by way of "substituting" another women's ovum. One method, for example, involves the donation of a fertilized ovum from a fertile woman to an infertile receipient woman. These include in-vitro fertilization, where the oocyte of a donor is surgically removed from the body, fertilized in a laboratory vessel (in-vitro), and then the fertilized ovum is non-surgically placed into the uterus of an infertile recipient woman (Lutjen, P, et al., "The Establishment and Maintenance of Pregnancy Using In Vitro Fertilization and Embryo Donation in a Patient with Primary Ovarian Failure," Nature, 307, 174 (1984)). Additionally, nonsurgical ovum transfer is a recently developed treatment for infertile women, involving the nonsurgical recovery of an in vivo fertilized human ovum from a fertile donor, and its nonsurgical transfer to an infertile recipient woman. These techniques are not directed to discerning the cause of the recipient woman's infertility.
An apparatus has been developed which is useful for embryonation and human embryo transfer, and for uterine examination and treatment. U.S. Pat. No. 4,533,345 describes a uterine catheter designed for nonsurgical, transcervical "probing of the uterus, non-surgically recovering pre-implantation embryos, flushing the uterus, testing for tubal patency, introducing a treative material into the uterus, and sampling endometrial or uterine tissue." Particularly, the uterine catheter in that invention is preferably used for non-surgical human embryo recovery in processess for human embryo transfer and artificial embryonation (Column 2, lines 33-43).
U.S. Pat. No. 4,533,345 thus teaches the practice of its invention to recover fertilized ova, and for probing and treating uterine and tubal factors.
It is also possible that some infertility may result from characteristics of a woman's ova. However, until recently, it has not been possible, except by surgical means, to recover an ovum, fertilized or unfertilized, or to assess its morphology. Detection of a fertilized ovum likewise has not been possible except by surgical means, or blood serum analysis, until after implantation. Additionally, the only method for determining the viability of any ovum after its recovery from a woman has been the clinical test of replacing it in the woman.
Applicant is aware of experiments performed on mice involving the sacrificing of the mice, and then the surgical removal and examination of fertilized and unfertilized ova.
There has long been a need for a method of precise, nonsurgical diagnosis and treatment of infertile women whose infertility cannot be explained by current state-of-the-art methods.